Device Dossier
inomed ISIS IONM - Patient monitor, nerve
Device Dossier for inomed ISIS IONM - Patient monitor, nerve (Patient monitor, nerve, Class IIb, sponsor Neuroclast). ARTG record, intended purpose, GMDN…
- GMDN category: Patient monitor, nerve
Intended purpose
inomed ISIS systems are intended for intraoperative neurophysiological monitoring for recording of electrophysiological signals and stimulating of neural and muscle tissues during surgery. The ISIS system is intended for use in operating theatres and intensive care units to measure and display electrical signals generated by the central and peripheral nervous systems. The system supports the clinical application of Electroencephalography (EEG), Electromyography (EMG), Somatosensory Evoked Potentials (SEP), Motor Evoked Potentials (MEP), Auditory Evoked Potentials (AEP) and Visual Evoked Potentials (VEP). The system is not intended for monitoring life- sustaining functions